Senior Scientist, Assay Development & Validation

BioTalent; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent is seeking a Staff Scientist, Assay Development in California to drive reagent formulation, assay chemistry optimization, and analytical validation for FDA-regulated molecular diagnostic products. You will work closely with cross-functional teams to ensure robust, manufacturable assay performance and contribute to commercialization strategies.

The role emphasizes stability studies, lyophilization, and validation activities, with exposure to ISO 13485 and CLSI guidelines.

Qualifications

• PhD with 5+ years in industry or MS with 8+ years of experience.
• Experience with molecular diagnostic development and FDA-regulated products preferred.
• Familiarity with Design Controls, FDA 510(k), ISO 13485, CLSI guidelines.

Responsibilities

• Reagent development and formulation for molecular diagnostics or IVD products.
• Assay chemistry optimization and analytical performance improvement.
• Stability studies, accelerated aging, shelf-life determination, and lyophilization.
• FDA-regulated product development and analytical validation.

Skills

Assay development

Molecular diagnostics

qPCR

PCR

Analytical validation

Design Controls

Industry experience

Education

PhD in a relevant field

MS in a relevant field

Tools

qPCR instruments

Lyophilization equipment

Job description

BioTalent is seeking a Staff Scientist, Assay Development in California to drive reagent formulation, assay chemistry optimization, and analytical validation for FDA-regulated molecular diagnostic products. You will work closely with cross-functional teams to ensure robust, manufacturable assay performance and contribute to commercialization strategies.

The role emphasizes stability studies, lyophilization, and validation activities, with exposure to ISO 13485 and CLSI guidelines.